摘要
目的对UniCel DXI800全自动磁性微粒子化学发光免疫分析系统(以下简称DXI800)的分析性能进行初步评价。方法选择雌二醇(E2)、泌乳素(PRL)、促卵胞生成素(FSH)、三碘甲状腺原氨酸(TT3)等4个项目,应用《临床实验室定量检测试验的初步评价批准指南》(EP10-A2)对其分析性能进行初步评价。结果 E2低、中、高值的总不精密度分别为7.79%、5.21%、4.48%,偏倚分别为-2.45%、-1.90%、-0.40%。FSH低、中、高值的总不精密度分别为3.58%、4.81%、4.71%,偏倚分别为6.84%、4.73%、0.93%。PRL低、中、高值的总不精密度分别为2.63%、3.10%、2.24%,偏倚分别为-0.03%、-0.65%、-0.50%。TT3低、中、高值的总不精密度分别为2.71%、1.60%、2.05%,偏倚分别为-0.01%、0.01%、-0.05%。E2、FSH、PRL、TT3 4个项目的截距、斜率、携带污染率、非线性、线性漂移等指标的t检验值均介于-4.6到4.6之间。结论 UniCel DXI800具有很好的分析性能,能满足临床标本检测的需要。
Objective To evaluate the performance of UniCel DXI800 automated chemiluminescence immunoassay system.Methods The indexes of E2,FSH,PRL,TT3 were detected according to the CLSI Document EP10-A2 preliminary evaluation of quantitative clinical laboratory methods：approved guideline.Results The high,medium,low total imprecision of E2 were 7.79%,5.21%,4.48%,the bias of them were-2.45%,-1.90%,-0.40%.The high,medium,low total imprecision of FSH were 3.58%,4.81%,4.71%,the bias of them were 6.84%,4.73%,0.93%.The high,medium,low total imprecision of PRL were 2.63%,3.10%,2.24%,the bias of them were-0.03%,-0.65%,-0.50%.The high,medium,low total imprecision of TT3 were 2.71%,1.60%,2.05%,the bias of them were-0.01%,0.01%,-0.05%.The indexes of slope,intercept, precision,carryover rate,linearity and total repeatability accorded with the prescriptive range.Conclusion The performance of DXI800 automated chemiluminescence immunoassay system is reliable and suitable for clinical laboratory to use.
出处
《检验医学与临床》
CAS
2013年第2期140-141,共2页
Laboratory Medicine and Clinic
